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Type(s) of Cancer
Sarcoma
Study Phase
Phase 3
Study Completion Date
August 2012
NCT00075582Uploaded 11-11-2020
Access via NCI by Request
PDS UID: nci-data-436
Vincristine, Dactinomycin, and Lower Doses of Cyclophosphamide With or Without Radiation Therapy for Patients With Newly Diagnosed Low-Risk Embryonal/Botryoid/Spindle Cell Rhabdomyosarcoma
Provider Information
Provider Data DescriptionNCT00075582-D1 is the only dataset for this manuscript (PMID 28211936). There is one row for each patient enrolled. The dataset contains the baseline patient characteristics, radiation received, delayed surgery received, adverse events and survival outcomes for patients on ARST0331 as reported in the manuscript.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis phase III trial is studying how well combination chemotherapy and radiation therapy work in treating patients with newly diagnosed low-risk rhabdomyosarcoma. Drugs used in chemotherapy, such as vincristine, dactinomycin, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet known which treatment regimen is more effective in treating low-risk rhabdomyosarcoma.
ConditionsAdult Rhabdomyosarcoma
Embryonal Childhood Rhabdomyosarcoma
Embryonal-botryoid Childhood Rhabdomyosarcoma
Previously Untreated Childhood Rhabdomyosarcoma
Intervention TypeProcedure: conventional surgery
Drug: dactinomycin
Drug: cyclophosphamide
Drug: vincristine sulfate
Radiation: radiation therapy
Drug(s)Drug: dactinomycin
Drug: cyclophosphamide
Drug: vincristine sulfate
Total Enrolled390
RandomizationNon-Randomized
Blinding MethodNone (Open Label)
Arms InterventionRegimen I (chemotherapy, radiotherapy) - Experimental
Regimen II (chemotherapy, radiotherapy, surgery) - Experimental
Secondary IDNCI-2009-00425
PubMed (PMID)N/A
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
New Zealand
Puerto Rico
Switzerland
Age Range49 Years and younger (Child, Adult)
Files: NCT00075582-D1
Data DictionaryNCT00075582-D1-Data-Dictionary_4.pdf
DATANCT00075582-D1-Dataset_3.csv
OTHERREADME.pdf
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